DGAP-News: WILEX AG publishes 9-month financial report 2011
(firmenpresse) - DGAP-News: WILEX AG / Key word(s): Interim Report/Quarter Results
WILEX AG publishes 9-month financial report 2011
13.10.2011 / 07:05
---------------------------------------------------------------------
PRESS RELEASE
WILEX publishes 9-month financial report 2011
- Income and earnings significantly improved
- FDA granted Fast Track designation for RENCAREX(R)
- US marketing and distribution agreement for diagnostics signed
- Further Phase I trial with WX-554 commenced
Munich, Germany, 13 October 2011. WILEX AG (ISIN DE0006614720 / WL6 /
Frankfurt Stock Exchange) today published its financial report for the
first nine months of the 2011 financial year (1 December 2010 - 31 August
2011) and reported on the status of the Company's projects.
Peter Llewellyn-Davies, Chief Financial Officer of WILEX AG, commented:
'Over the past nine months we successfully completed the integration of our
two subsidiaries, continued the development of our product candidates and
completed new and important partnerships. During this reporting period we
generated sales revenue and other income of EUR 5.6 million, more than a
fourfold increase compared with the previous year.'
Business performance, research and development activities in 2011
The process related to the interim analysis for efficacy for the
therapeutic RENCAREX(R) commenced in January 2011. This involves collecting
the data of all 864 patients, analyses by radiologists of some 30,000 CT
scans, entering all data in databases and quality control. The data will be
analysed by an external service provider and the results presented to the
Independent Data Monitoring Committee (IDMC). We expect the IDMC to make
its recommendation during the fourth quarter of 2011. Whilst the data
remain blinded for WILEX, they will nonetheless provide critical
information regarding the endpoint of the trial - disease-free survival.
The US Food and Drug Administration (FDA) granted RENCAREX(R) Fast Track
designation in October 2011. This milestone triggers a payment of USD 2.5
million from the US partner Prometheus Laboratories Inc. (Prometheus), with
whom WILEX signed a licence agreement for RENCAREX(R) at the end of April
2011. Fast Track designation in the United States is a process designed to
expedite the review of drugs to treat serious diseases which fill an unmet
medical need.
The serine protease inhibitor MESUPRON(R) is in a Phase II programme and
currently tested in patients with metastatic, HER2 receptor negative breast
cancer. Patient recruitment was completed in the second quarter of 2011.
In September 2011 WILEX started a further Phase I trial with the
orally-administered version of the MEK inhibitor WX-554 in healthy
volunteers. The small-molecule inhibitor is one of the programmes acquired
from UCB for further clinical development. The Phase I trial with the
orally-administered WX-554 follows the successfully completed Phase I trial
with the intravenous formulation and will therefore provide an estimate of
the drug candidate's bioavailability.
The Pre-BLA Meeting for the diagnostic candidate REDECTANE(R) took place in
the second quarter. The FDA confirmed at this meeting that the Phase III
REDECT trial delivers reasonable evidence of the diagnostic efficacy and
safety of REDECTANE(R). The FDA suggested that WILEX and IBA might consider
an outcomes based study to provide additional evidence of clinical benefit
before BLA filing. WILEX andIBA have discussed the trial design and
strategy with the medical advisory board and will subsequently discuss this
with the FDA. The second set of issues discussed with the FDA concerns
matters related to the manufacturing of REDECTANE(R) and is being addressed
by IBA and WILEX respectively.
The WILEX Inc. production facility in Cambridge, MA, USA, was certified to
both ISO 9001:2008 and 13485:2003 in August 2011. The ISO certifications
are the prerequisite for WILEX Inc. to proceed with its Oncogene Science(R)
business - to manufacture and distribute biomarker tests. WILEX Inc.
further expanded its customer base in the reporting period. WILEX Inc.
entered into an exclusive co-marketing and distribution agreement in
October 2011 with American Laboratory Products Company Inc. (ALPCO) for the
commercialisation of the Serum HER-2/neu ELISA test in North America (USA
and Canada).
Heidelberg Pharma AG has successfully expanded its preclinical service
business and reports increasing sales revenue.
Financial results of the first nine months of 2011
The WILEX Group generated sales revenue and other income of EUR 5.6 million
in the first nine months of 2011 (previous year: EUR 1.2 million). Sales
revenue totalled EUR 4.7 million (previous year: EUR 0). The revenue from
deferred income in the Therapeutics segment relating to the Prometheus
transaction of EUR 3.6 million accounts for a large portion of that amount.
The Diagnostics segment accounts for EUR 0.2 million of the sales revenue,
and the Customer Specific Research segment for EUR 0.9 million. WILEX
Groups' internal sales revenue of EUR 0.3 million was not taken into
account. Other income was EUR 0.8 million (previous year: EUR 1.2 million).
This arises from prepayments received for research projects accrued and
recognised as other income in line with project costs using the
percentage-of-completion method.
Operating expenses including depreciation and amortisation were EUR 18.4
million and thus slightly lower than the previous year (EUR 18.5 million),
despite the consolidation of the subsidiaries. Research and development
costs at 73.8% account for the majority of operating expenses. These were
EUR 13.6 million in the first nine months of 2011 and thus 9.9% lower than
2010 (EUR 15.1 million). This decrease stems from the progress of the
clinical trials and the resulting decrease in expenditures.
The ongoing clinical development of the monoclonal antibody Girentuximab
(for RENCAREX(R) and REDECTANE(R)) accounted for 48.8% of research and
development costs (previous year: 47.6%). As expected, this figure was
lower than 2010 in absolute terms, reflecting the progress of the two Phase
III trials. The uPA programme involving the small-molecule drug candidate
MESUPRON(R) accounted for 23.8% of the research and development costs
(previous year 35.1%) which is due to the Phase II breast cancer trial. The
previous year's figure included expenses for the Phase II trial in the
pancreatic cancer indication, which was completed in 2010. The other
projects, which mainly comprise the programmes acquired from UCB, account
for 15.0% of research and development costs. Expenditures have declined
compared to the previous year (17.3%) as in 2010 they included the costs
for a Phase I trial of WX-554, which was completed during the year. The
Customer Specific Research segment incurred research and development costs
for the first time in the reporting period due to the integration of
Heidelberg Pharma AG; these accounted for 12.4% of the Group's total
research and development costs.
The WILEX Group posted a loss of EUR 13.2 million for the first nine months
of 2011. This represents an improvement of 23.2% compared to the previous
year (EUR -17.2 million), largely due to higher income and lower research
and development costs. Earnings per share improved by 38.7% to EUR -0.65
(previous year: EUR -1.06) as a result of the lower loss for the period and
the increase in the number of shares.
At the end of the third quarter of 2011, the WILEX Group had cash and cash
equivalents of EUR 8.1 million (30 November 2010: EUR 1.9 million; 31
August 2010: EUR 7.8 million). The Company's equity situation improved in
the reporting period thanks to the non-cash capital increase as a result of
acquiring Heidelberg Pharma. Equity as of 31 August 2011 was EUR 4.6
million (30 November 2010: EUR -1.3 million).
Outlook
WILEX adjusted the financial guidance for the current financial year in the
half-yearly financial report 2011, taking into account the progress of its
projects and the licence agreement for RENCAREX(R) with Prometheus. This
adjusted guidance still applies.
WILEX expects the following clinical milestones in the coming months:
WILEX continues to prepare the approval application for REDECTANE(R)
jointly with its partner IBA. WILEX and IBA have been planning to file for
approval in late 2011. Due to the on-going process and pending discussions
with the FDA this timeline is becoming more and more ambitious and may
change according to the progress and outcome of these on-going regulatory
discussions. The next FDA meeting is expected in the fourth quarter to
discuss the study design of the outcomes based study. Following the meeting
with the FDA WILEX will update the market regarding the approval process
and timeline for REDECTANE(R).
The IDMC recommendation from the interim analysis in the RENCAREX(R) Phase
III ARISER trial is expected during the fourth quarter of 2011.
Under the agreement signed in late April 2011 with Prometheus, the US
partner for RENCAREX(R), WILEX will review and decide whether to take over
an approved and marketed product for Europe or receive a compensation
payment of USD 15.0 million after six months or USD 20.0 million after
twelve months following the signature of the agreement.
WILEX will continue the Phase I programme with the MEK inhibitor WX-554 and
start a trial with cancer patients in early 2012. The final data of
progression-free survival from the Phase II trial of MESUPRON(R) in HER2
receptor negative breast cancer are expected during 2012.
WILEX Inc. will work with the new marketing and distribution partner ALPCO
on the expansion of its customer base for the HER-2/neu ELISA test.
Heidelberg Pharma AG will continue the expansion of contract-based business
activities.
Key figures 9M 2011 1) 9M 2010 1) Change1 The reporting period begins on 1 December and ends on 31 August
Earnings EUR '000 EUR '000 in %
Income 5,552 1,244 446.3
of which sales revenue 4,738 0 n/a
of which other income 814 1,244 (34.6)
Other expenses (18,416) (18,479) (0.3)
of which research and development costs (13,595) (15,095) (9.9)
Operating result (12,864) (17,235) (25.4)
Earnings before tax (13,228) (17,217) (23.2)
Net loss for the period (13,230) (17,222) (23.2)
Earnings per share in EUR (0.65) (1.06) (38.7)
Balance sheet as of end of period
Total assets 32,398 10,994 194.7
Cash and cash equivalents 8,073 7,762 4.0
Equity 4,638 4,530 2.4
Equity ratio2) in % 14.3 41.2 (65.3)
Cash flow
from operating activities (3,370) (13,934) (75.8)
from investing activities (399) (11) n/a
from financing activities 9,907 18,296 (45.9)
Employees
Employees as of the end of the period3) 119 72 65.3
Employees - average for the reporting
period3) 101 72 40.3
2 Equity/total assets
3 Including WILEX Inc. (2011), Heidelberg Pharma (2011) and members of the
Executive Management Board
Rounding of exact figures may result in differences.
The 9-month Financial Report 2011 including the consolidated financial
statements prepared in accordance with IFRS has been published on the
Company's website: www.wilex.com.
Invitation to the conference call
On 13 October 2011, WILEX will hold a public conference call for media,
analysts and investors in English at 3:00 p.m. CET. Please dial in ten
minutes before the conference call using the following dial-in numbers:
1. Germany: +49 69 6677 75756
2. UK: +44 20 3003 2666
3. USA: +1 212 999 6659
4. USA Freephone: +1 866 966 5335
You will be welcomed by an operator taking your name and company. The
presentation for the conference will be available for download from
http://www.wilex.com/ at 2:00 p.m. CET. A replay of the conference will be
available from 14 October on the website
http://www.wilex.de/press-investors/presentations/.
About WILEX AG
WILEX AG is a biopharmaceutical company based in Munich, Germany. Focused
on oncology, the company has a broad portfolio of near-to-market
therapeutic and diagnostic products for the targeted treatment and specific
detection of various types of cancer. The company's therapeutic product
candidates are based on antibodies and small molecules. Through its US
subsidiary WILEX Inc. in Cambridge, MA, WILEX markets a portfolio of
research use only and in vitro diagnostic tests under the brand Oncogene
Science(R). These diagnostic tests could be developed as companion
diagnostics in clinical trials and for therapy monitoring. The wholly owned
subsidiary Heidelberg Pharma AG gives WILEX access to an attractive and
highly promising antibody drug conjugate technology platform and a
pre-clinical service business. The business model of WILEX covers the
entire value chain in the oncology market and comprises research,
technology, development collaboration as well as sales and marketing.
WILEX's customers and partners include leading international pharmaceutical
companies. ISIN DE0006614720 / WKN 661472 / Symbol WL6
Contact
Katja Arnold (CIRO)
Corporate Communications
WILEX AG
Grillparzerstr. 10
81675 Munich, Germany
Tel.: +49 (0)89-41 31 38-126
Fax: +49 (0)89-41 31 38-99
Email: investors(at)wilex.com
This communication contains certain forward-looking statements relating to
the Company's business, which can be identified by the use of
forward-looking terminology such as 'estimates', 'believes', 'expects',
'may', 'will', 'should', 'future', 'potential' or similar expressions or by
a general discussion of the Company's strategy, plans or intentions. Such
forward-looking statements involve known and unknown risks, uncertainties
and other factors, which may cause our actual results of operations,
financial position, earnings, achievements, or industry results, to be
materially different from any future results, earnings or achievements
expressed or implied by such forward-looking statements. Given these
uncertainties, prospective investors and partners are cautioned not to
place undue reliance on such forward-looking statements. We disclaim any
obligation to update any such forward-looking statements to reflect future
events or developments.
End of Corporate News
---------------------------------------------------------------------
13.10.2011 Dissemination of a Corporate News, transmitted by DGAP - a
company of EquityStory AG.
The issuer is solely responsible for the content of this announcement.
DGAP's Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de
---------------------------------------------------------------------
Language: English
Company: WILEX AG
Grillparzerstr. 10
81675 München
Germany
Phone: +49 (0)89 41 31 38 - 0
Fax: +49 (0)89 41 31 38 - 99
E-mail: info(at)wilex.com
Internet: www.wilex.com
ISIN: DE0006614720
WKN: 661472
Listed: Regulierter Markt in Frankfurt (Prime Standard);
Freiverkehr in Berlin, Düsseldorf, München, Stuttgart
End of News DGAP News-Service
---------------------------------------------------------------------
142147 13.10.2011
Themen in dieser Pressemitteilung:
Unternehmensinformation / Kurzprofil:
Datum: 13.10.2011 - 07:05 Uhr
Sprache: Deutsch
News-ID 75605
Anzahl Zeichen: 10663
contact information:
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 213 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"DGAP-News: WILEX AG publishes 9-month financial report 2011"
steht unter der journalistisch-redaktionellen Verantwortung von
WILEX AG (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
